The high purity of our highly potent active pharmaceutical ingredients guarantees our customers effective processes and consistently top quality for their products. Continuous enhancement of our knowledge enables them to maintain compliance with changing regulations and ensures a long-term drug supply.
Pharmaceutical Ingredients
Your specialist for highly potent anti-cancer APIs and CDMO services
Cancer cases are globally on the rise, causing an increasing demand for their treatment. Highly Potent Active Pharmaceutical Ingredients (HPAPIs) are the key compounds for chemotherapies, combination therapies in particular. Business Line Pharmaceutical Ingredients at Heraeus Precious Metals specializes in the production of generic HPAPIs as well as the exclusive synthesis of cytotoxic compounds from the research stage to registration to market launch.
Heraeus recently made a significant multi-million Euro investment building up its manufacturing capacity for platinum-based pharmaceutical ingredients to fight cancer. This is the company’s response to the global increase in demand for cancer drugs while consolidating its position as the global market leader for platinum-based active ingredients.
Generic HPAPIs
Generic HPAPIs
CDMO
Contract Manufacturing of Highly Potent APIs (CDMO)
Many highly active ingredients require special handling, compelling manufactures to take appropriate protective measures. Heraeus with its broad experience in chemistry, processes and the appropriate equipment is a partner fully dedicated to the manufacturing of HPAPIs.
Cancer cases are steadily on the rise across the globe. Highly potent active pharmaceutical ingredients (HPAPIs) are the key compounds and most relevant to combination therapies in particular. Both developing new active ingredients and optimizing lab syntheses for mass production require the profound knowledge of experts. Moreover, HPAPIs have to be handled in high-containment facilities with extreme care.
Heraeus has the appropriate equipment and extensive experience dealing with such challenging molecules. We support our customers in the exclusive synthesis of cytotoxic compounds from the research stage to registration and market launch.
With the below comprehensive services, our customers are free to focus on their core business and transform their innovative ideas into commercial products:
- The high-containment systems ensure the highest technological standard (OELs < 10 ng/m3)
- Extensive knowledge and experienced project teams
- Batches from gram to fully commercial scale
- Antibody Drug Conjugates (ADCs)
- Photochemistry reactions in batch and continuous flow production
- Comprehensive GMP documentation and outstanding global regulatory support – a full range of services under one roof
- Strictly protected customers’ IP
With our comprehensive knowledge in process chemistry and project management, we always create tailor-made offers to you as our clients and guarantee time-efficient and cost-effective solutions for any challenges you may face.
Quality Competence
Quality Competence
Extensive analytical capabilities, quality assurance and the full reliability of a global partner are extremely important for the pharmaceutical industry. Heraeus constantly secures the quality of highly active pharmaceutical ingredients, strictly follows international regulations and prepares and maintains all documentation for initial and existing registrations worldwide.
Regulatory Affairs
A successful registration based on transparent communication not only permits entry to markets all over the world; it also confirms that Heraeus meets the strictest requirements for the quality of its HPAPIs.
Preparation of Dossiers
- registration documents according to current ICH standards
- all relevant pharmacopeias (e.g. Ph. Eur., BP, USP, JP, IP, CP)
- chemical-pharmaceutical dossiers (CMC, Module 3): technical writing of the complete part - also based on customers’ raw data
- CEPs available for all HPAPIs with a pharmacopeial monograph
- expertise in eCTD submissions and non-eCTD electronic submissions (NeeS)
Management of Registration Procedures
- registration procedures consistent with current guidelines and predetermined timeframes
- assistance in providing additional technical information
- competent personal contact at all stages of the registration process
Life Cycle Management
- regulatory support for existing products
- continuous improvement of documentation
- established change control system
- professional change management with customers and authorities in line with the current Variation Regulations
Quality Assurance
Heraeus constantly secures the outstanding quality of its highly active pharmaceutical ingredients and ensures a continuous improvement of quality, safety and environmental standards through its comprehensive services:
- Release of HPAPIs
- Supervision of GMP compliance & quality
- GMP compliant document management
- Auditing of internal departments as well as external suppliers
- Training of staff and management
- QA agreements
Quality Control
Heraeus is equipped with the most state-of-the-art analytical techniques: process controls, analysis of raw materials, intermediates, and release testing of HPAPIs are conducted in compliance with cGMP and ICH guidelines.
Our Services
- Release of raw materials
- Quality control of intermediates, in-process controls and HPAPIs
- Stability testing of HPAPIs and raw materials (if required)
- Full characterization and qualification of reference standards
- Development and validation of analytical methods
- Identification of unknown impurities / degradation products
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